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临床试验/NCT02133066
NCT02133066已完成不适用

The Effect of Bedside Ultrasound Assistance on the Proportion of Successful Infant Lumbar Punctures in a Pediatric Emergency Department: A Randomized Controlled Trial

Children's Hospital of Philadelphia2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2014年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
128
试验地点
2
主要终点
Percentage of Successful First Attempt Lumbar Punctures in the Ultrasound-assisted Group as Compared to the Non-ultrasound Assisted Group

研究概览

简要总结

The reported rate of unsuccessful spinal taps in children, especially young infants, is high. Our hypothesis is that ultrasound assistance can improve the success rate of spinal taps.

详细描述

The reported rate of unsuccessful spinal taps in children is high. At the Children's Hospital of Philadelphia (CHOP), quality improvement data demonstrates a failure rate of ~40-50%. Research has shown that bedside ultrasound can improve visualization and improve the success rate of spinal taps. Increasing the proportion of successful spinal taps in the emergency department could significantly reduce the rate of unnecessary hospitalizations, additional interventional procedures and antibiotic use. Our objective is to determine if bedside ultrasound-assisted site marking will increase the proportion of first attempt successful spinal taps. This will be a prospective, randomized controlled study that will take place over the course of 18 months with the goal to recruit a sample of approximately 128 patients. We will recruit subjects from the CHOP Emergency Department. The patients will be randomized into an ultrasound-assisted group versus a non-ultrasound-assisted group. Our hypothesis is that bedside ultrasound-assisted site marking will increase the number of successful spinal taps.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
— 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Less than or equal to six months of age
  • Plan for diagnostic or therapeutic lumbar puncture as per front line clinician
  • Availability of a study sonographer to perform bedside ultrasound

排除标准

  • Known spinal cord abnormality (e.g., tethered cord, spina bifida)

研究组 & 干预措施

US-Assisted site marking for Lumbar Punctures (LP)

Active Comparator

Mindray M7 Ultrasound marking

干预措施: Bedside Ultrasound-Assisted Site Marking (Procedure)

US-Assisted site marking for Lumbar Punctures (LP)

Active Comparator

Mindray M7 Ultrasound marking

干预措施: Mindray M7 Ultrasound (Device)

Routine lumbar puncture

Placebo Comparator

These patients will receive no ultrasound-assisted site marking prior to lumbar puncture; The patients will simply have a "standard-of-care" spinal tap performed by the clinician

干预措施: Routine lumbar puncture (Procedure)

结局指标

主要结局

Percentage of Successful First Attempt Lumbar Punctures in the Ultrasound-assisted Group as Compared to the Non-ultrasound Assisted Group

时间窗: 30 minutes

First attempt success in ultrasound-assisted group compared to first attempt success in non-ultrasound assisted group

次要结局

  • Percentage of Overall Success of Lumbar Punctures in the Ultrasound-assisted Group Versus the Non-ultrasound-assisted Group(30 minutes)
  • Length of Hospitalization in Ultrasound-assisted Lumbar Puncture Patients Versus Non-ultrasound-assisted Patients(Participants will be followed for the duration of the hospital stay, an expected average of 2 days)
  • Length of Antibiotic Use in Ultrasound-assisted Lumbar Puncture Patients Versus Non-ultrasound-assisted Patients(Participants will be followed until discontinuation of antibiotics, an expected average of 2 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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